Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
136
Countries
1
Sites
1
Atrial fibrillation
Key facts
- Sponsor
- Semmelweis University
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 20 Jan 2026 → ongoing
- Decision date (initial)
- 2025-10-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Atrial fibrillation
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Semmelweis University
- Sponsor organisation
- Semmelweis University
- Address
- Ulloi Ut 26
- City
- Budapest VIII
- Postcode
- 1085
- Country
- Hungary
Scientific contact point
- Organisation
- Semmelweis University
- Contact name
- Dr. Drobni Zsófia Dóra, PhD
Public contact point
- Organisation
- Semmelweis University
- Contact name
- Dr. Drobni Zsófia Dóra, PhD
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ongoing, recruiting | 136 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Semmelweis University
Department of Cardiology, Varosmajor Utca 68, Kerulet, Budapest XII
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Hungary | 2026-01-20 | 2026-01-21 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-28 | Hungary | Acceptable 2025-10-08
|
2025-10-22 |